Announced details
Domestic Phase III clinical trial targeting pediatric patients with achondroplasia aged 2–14
Four additional sites obtained approval from their institutional review boards (IRBs)
As of today, the cumulative number of clinical trial sites able to enroll patients is 10.
Orphan drug designation
Ministry of Health, Labour and Welfare
The locations of the clinical trial sites are shown in a figure, but no specific details are provided in the text.
No impact on full-year earnings for the fiscal year ending March 2027
The company does not address Contract Value / Offering price.
| Item | Details |
|---|---|
| Names of Products / Services Covered | umedaptanib pegol (RBM-007, anti-FGF2 aptamer) |
| Applicable area | Domestic Phase III clinical trial targeting pediatric patients with achondroplasia aged 2–14 |
| Award/certification name | Orphan drug designation |
| Awarding / certifying body | Ministry of Health, Labour and Welfare |
| Location | The locations of the clinical trial sites are shown in a figure, but no specific details are provided in the text. |
| Location scale | The cumulative number of clinical trial sites able to enroll patients is 10. The company plans to expand the trial to a total of 16 sites. |
| Quantitative Effects | Four additional sites obtained approval from their institutional review boards (IRBs) |
| Usage history | As of today, the cumulative number of clinical trial sites able to enroll patients is 10. |
| Impact on Business Performance | No impact on full-year earnings for the fiscal year ending March 2027 |
Items this document does not state (9)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.Because the trial targets pediatric patients with a rare disease who are undergoing growth, collaboration with highly specialized medical institutions is important. Expanding the number of clinical trial sites is expected to improve patient access and facilitate smooth subject enrollment.